[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520676":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":38,"locations":48,"responsibleParty":80,"collaborators":82,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":42,"eligibilityCriteria":95,"healthyVolunteers":92,"sex":96,"minAge":97,"maxAge":42,"enrollmentInfo":98,"targetDuration":42,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":51,"whyStopped":42,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Finerenone","EXPERIMENTAL","Participants in this study arm will receive the study drug Finerenone.\n\nInitial Dosing: Dosing regimen of 10 mg or 20 mg once daily (QD), based upon screening eGFR. For eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2, participants will start at 10 mg QD. For eGFR ≥ 60 mL\u002Fmin\u002F1.73m\\^2, participants will start at 20 mg QD.\n\nDose Titration: Dose will be titrated according to potassium levels. For participants initiated at 10mg, the dose will be up titrated to 20 mg if the potassium level measured after 2 weeks is ≤4.8 meq\u002FL and eGFR has not decreased by \\>30 percent of the screening visit value. Study drug dosing may be titrated up or down per the below.\n\nPotassium level: ≤ 4.8\n\n* If on lower dose, up-titrate to higher dose\n* If on higher dose, continue on the same dose\n\nPotassium level: 4.9-5.5 = continue same dose\n\nPotassium level: \\>5.5 = withhold study drug and recheck potassium within 3 days. Re-initiate study drug at the 10 mg dose once potassium is ≤4.8 meq\u002FL.",[13],"Drug: Finerenone Oral Tablet",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants in this study arm will receive the placebo comparator.\n\nInitial Dosing: Dosing regimen of 10 mg or 20 mg once daily (QD), based upon screening eGFR. For eGFR \\\u003C 60 ml\u002Fmin\u002F1.73m\\^2, participants will start at 10mg QD. For eGFR ≥ 60ml\u002Fmin\u002F1.73m\\^2, participants will start at 20 mg QD.\n\nDose Titration: Dose will be titrated according to potassium levels. For participants initiated at 10 mg, the dose will be up titrated to 20 mg if the potassium level measured after 2 weeks is ≤4.8 meq\u002FL and eGFR has not decreased by \\>30 percent of the screening visit value. Study drug dosing may be titrated up or down per the table below.\n\nPotassium level: ≤ 4.8\n\n* If on lower dose, up-titrate to higher dose\n* If on higher dose, continue on the same dose\n\nPotassium level: 4.9-5.5 = continue same dose\n\nPotassium level: \\>5.5 = withhold study drug and recheck potassium within 3 days. Re-initiate study drug at the 10 mg dose once potassium is ≤4.8 meq\u002FL.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Finerenone Oral Tablet","Blinded study of finerenone vs. placebo in kidney transplant recipients. Participants will take finerenone or placebo once daily for 12 months. The drug will be up- or down-titrated according to potassium levels.",[9],[27],"Kerendia",{"type":22,"name":15,"description":24,"armGroupLabels":29,"otherNames":30},[15],[31],"Sugar pill",[33,36],{"name":34,"affiliation":5,"role":35},"Amy Mottl, MD, MPH","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":5,"role":35},"Prabir Roy-Chaudhury, MD, PhD",[39,44],{"name":34,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","919-445-2641",null,"amy_mottl@med.unc.edu",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Sara Kelley, MPH","919-445-2658","sara_kelley@med.unc.edu",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"UNC Eastowne Kidney Transplant Clinic","RECRUITING","Chapel Hill","North Carolina","27514","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-79.05584,35.9132,{"lat":61,"lon":60},[64,65,69,70,71,74,76,78],{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},{"name":66,"role":40,"phone":67,"phoneExt":42,"email":68},"Sora Lee, BA","919-445-2657","leesora@email.unc.edu",{"name":34,"role":35,"phone":42,"phoneExt":42,"email":42},{"name":37,"role":35,"phone":42,"phoneExt":42,"email":42},{"name":72,"role":73,"phone":42,"phoneExt":42,"email":42},"Elizabeth Kotzen, MD, MSCR","SUB_INVESTIGATOR",{"name":75,"role":73,"phone":42,"phoneExt":42,"email":42},"Mark Kleman, DO",{"name":77,"role":73,"phone":42,"phoneExt":42,"email":42},"Randal Detwiler, MD",{"name":79,"role":73,"phone":42,"phoneExt":42,"email":42},"Charles Jennette, MD",{"type":81,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[83,86,88],{"name":84,"class":85},"Bayer","INDUSTRY",{"name":87,"class":6},"Weill Medical College of Cornell University",{"name":89,"class":6},"University of Cincinnati","100520676","phase-2-the-effect-of-finerenone-in-kidney-transplantion-recipients-the-effektor-study-100520676",false,"NCT06059664","The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study","Clinical Trial Inclusion Criteria:\n\n* Adult kidney transplant recipients ≥ 18 years\n* 1 to 10 years post kidney transplantation from a deceased or living donor\n* Stable kidney allograft function (within 20% baseline eGFR) and based on the clinical judgement of the investigator\n* Preserved kidney allograft function defined as an eGFR ≥ 25 mL\u002Fmin\u002F1.73 m\n* Urine albumin:creatinine ratio (UACR) ≥30 ug\u002Fmg\n* Ability of the participant, or their legally authorized representative, to provide informed consent\n* Contraceptive requirements:\n* Women of non-childbearing potential do not need to undergo pregnancy testing or agree to use adequate contraception. Non-childbearing potential is defined as documented hysterectomy, bilateral salpingectomy, oophorectomy or postmenopausal females (amenorrhea for 12 months without an alternative medical cause). A single high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state.\n* Women of childbearing potential can only be included if a pregnancy test is negative at the screening visit and if they agree to use adequate contraception during the study and until 8 weeks after the last study intervention dose. Adequate contraception is defined as an intrauterine device, implant or combined oral contraceptive with a physical barrier (e,g., condom).\n\nAdditional Inclusion Criteria for Kidney Biopsy Sub-study:\n\n* Willingness to undergo research study biopsies at screening and following the 12 month treatment period\n* Ability to safely discontinue antiplatelet or anticoagulant treatments\n* No known intrinsic bleeding diathesis\n* Hemoglobin \\>9.0 g\u002FdL; Platelets \\> 100,000; International Normalised Ratio (INR) \\\u003C1.4 on the day of kidney biopsy\n* Body mass index \\\u003C40\n* Blood pressure controlled on the day of biopsy to \\\u003C160\u002F90\n\nMedical Condition Exclusion Criteria:\n\n* Documented recurrent lupus nephritis, ANtineutrophilic Cytoplasmic Antibody (ANCA) vasculitis, membranoproliferative glomerulonephritis (including C3 glomerulopathy)\n* History of solid organ transplantation other than kidney\n* Acute kidney injury requiring dialysis within 6 months prior to screening\n* Uncontrolled hypertension with a sitting Systolic Blood Pressure (SBP) ≥180 mmHg or Diastolic Blood Pressure (DBP) ≥100 mmHg\n* Any indication for treatment with a steroidal MRA\n* UACR \\>3500 mg\u002Fg at screening. This may be reassessed if one of the three first morning urine samples is \\>3500 mg\u002Fg at the screening visit\n* CV event within 3 months prior to screening (heart failure requiring acute care, myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, elective coronary artery bypass grafting)\n* Elective percutaneous coronary intervention within 1 month prior to screening\n* Known hypersensitivity to the study treatment\n* Addison's disease\n* Hepatic insufficiency classified as Child-Pugh C\n* Pregnancy, breast feeding or intention to become pregnant\n\nConcomitant Therapies Exclusion Criteria:\n\n* Concomitant therapy with spironolactone, eplerenone, sacubitril\u002Fvalsartan combination, or potassium-sparing diuretic which cannot be discontinued at least 2 weeks prior to screening\n* Simultaneous use of Angiotensin-Converting Enzyme Inhibitors (ACEI) and Angiotensin Receptor Blockers (ARB), without being able to discontinue one of these at least 2 weeks prior to screening\n* Use of potent CYP3A4 inhibitors or inducers (to be stopped at least 7 days before randomization).\n\nOther Exclusion Criteria:\n\n* Participation in the MRI Study is excluded for certain pacemakers, electronic implants, shrapnel of the eye and certain types of aneurysm clips.\n* Any other history, condition, or therapy which could, in the opinion of the investigator, affect compliance with the study treatment and procedures\n* Close affiliation with the investigational site, investigators or staff\n* Simultaneous participation in another interventional trial within 30 days prior to randomization","ALL","18 Years",{"count":99,"type":100},100,"ESTIMATED","INTERVENTIONAL",[103],"PHASE2","EFFEKTOR is a vanguard, multicenter, phase 2 randomized, double blinded, placebo controlled clinical trial to determine the feasibility, tolerability, safety, and efficacy of finerenone in kidney transplant recipients (KTRs). One hundred fifty (150) KTRs will be randomized in a 2:1 ratio of finerenone to placebo, with two embedded substudies: (i) a kidney biopsy substudy in 50 participants who undergo a research kidney biopsy prior to randomization and at the end of active treatment; and (ii) a functional MRI (fMRI) substudy in 50 participants who undergo fMRI prior to randomization and at the end of active treatment.",[106],"Kidney Transplant; Complications",[9,108,109,110,111,112,113],"Cardiovascular Outcomes","Albuminuria","eGFR decline","Congestive Heart Failure","Kidney biopsy","Functional MRI","2026-04-09",{"date":116,"type":117},"2026-04-14","ACTUAL",{"date":119,"type":117},"2024-04-23",{"date":121,"type":100},"2027-12-31",{"name":5,"class":6},1]